form 1EC1 Study Number’ INCLUSION CRITERIA A subject wile eligible for sudy participation i helshe meets the flowing erterta 1. The subject's logal representatative has younlarly signed and dated an approved informed consent form alter the nelure ofthe study has been explained and the subject and the subject's legally autharized representalive have had the oppartunity to ask questions, and before any siudy-specitc pracedures are performed, The consent forms must be approved by an Insitulonal Review Board (\RBV/indepencent Ehies Commitee JEG) (see Section 8.3, Subject Infammation and onsen), 2, Subjects a ate or female between 3 and 10 years of ap, inclusive tthe ime othe screening vist. 5. Subject has a clagnos's of partial seizures wih or without secondary generalization, This agnosis must be supported by he folowing: 4. Observed ictal events consistent with partial seizures with or without secondary generalization that is documented by retabie observers such as family members, caregivers, or medical personnel. ‘anda east one ofthe followin too: b, AN EEG at some time in the past demonstrating focal abnormalities consistent with parte seizures OR, inthe absence of a demonstrable EEG abnormality as defined above: ‘ MRIICT sean evidence of focal CNS lslon consistent wth partl seizures. 4, Subject weighs at east 18kg (28189) 5, Subjectis ona stable dose of one or wo antiepileptic dns) oer than valproate, wich ‘may or may not be inducers of va enzymes, for a least one month air tate Baseline Patod 6. Subjocs at the tie of study ent, ot akg valproate oe curently racolving Valproate reslngin 8 vough concerto fsa ha 40 meg he Seroering Vi 7, Subjects paréncaregiver hes tne abit to keep an accurate setzure dary. 6, Sublecthes a history of atest fur pal seizures per month inte two manths pir to Screening, : 9. Subjac is judged to bain generaly good health based upon the resus ofa mecical history, physical examination, laboratory profle and 12eadeletrocardograrn (ECG) {as described in Secon S31, Effcacy and Safety Measurements fo bo Assessed and Flow cher).Ot { \ foom 1EC2 Study Number : 2 es cS a SESSA EXCLUSION CRITERIA ‘A subject wil be excluded from the study ifhe/she meets any ofthe following criteria: 4, Subject has a history of any ofthe flowing: Lennox-Gastaut syndrome; primary generalized seizures; infantle spasms; mixed setzue disorders including atypical absence, myoclonic, or atoic seizures; pseudoseizures or Epilepsia Partials Continuans. 2, Subject has had status epleptcus in the past 6 months prior to Screening 3, Subject has a history af cardiac (Including dnicaly important abnormality on ECG), rena psychlatic (including psychosurgen), oncologic, endocrinologia, metabolic, pancreatic or hepatic dlsease (Including cncal or serological history of hepatitis), or urea cycle cisorder which would confound the interpratation ofthe study results, 4, Suidject has an expanding CNS neoplasm, active CNS infection, demyelinating disease, degeneralve neurolegcalcsease, progressive encephalopathy, or any progressive CNS disease. 5. Subject has a platelet count lass than or equal io 100,000/uL at screening. 6. Subject has a blood chemisty ALT andlor AST value(s) greater than or equal to two (2) times the upper limit of normal (ULN) al screening. 7. Subject requires anticoagulant drug therapy. 48, Subject is not expected to be able to maintain the same dose of ali pre-study AEDs, other than valproate, throughout the study. 8. Subject is receiving systemic chernotherapy. 10, Subject recolved any depot crug by Injection within 20 days prior to screening. 14, Subject has taken lamotrigine, felbamate, or pemoline, within the past three months prior to seroening, 412, Subject has been en the kelogenic cit within the 30 days prior o the screening visit 43, Subject is pregnant, 14, Subjects considered by the investigator to be @ non-responder to valproate forthe tfeatment of eallepsy (eg, Despite an adequate tal wth serum concentrations of 60 meg! ‘mL or greater, subject cornues to have inadequate selzure contol) 15, Subject has a history of a significant allege reaction to valproate or drugs siriler to, valproate, - 16, Subject has received any ivasigational drug within tha last tity (20) days prior to screening. 417. Subject previcusly participated inthis study as @ randomized subject, 18, Subject is currently or plans to participate in another experimental study curing the course ofthistia or ° ° 419, For any reason, subject Is considered by the Investigator fo be an unsuitable candidate to receives °- Sprinkle Capsules, o wil not be able to partcipatein all study procedures (e.g. due to suficienty severe static cognitive Impairments.) ‘mana 4 ypage 4 Study Number Subject Number of ao fa Investigator Number LLLLLI Subject initials SCREENING 1. Birth date 2, Gender |. Race {Check att oe) | taplatio) Ca wie Cn oaican OY Hispanic Coe ocx Ashe Cis asian Cooter (aie as wea —— 1, Was EEG performad prior to enroliment? (yes cemgiale numba 2 thi eon) swe Yves 3, Was MRIGT performed prior to enrollment? yee cama nimear4in bs eer) ‘Panne Ch ves Date of ssessment bo Loaves 2. G perfo TAL JI aels] 7 Date MRUCT performed nl ane WETE — {Gece esoneaie) | (Gracies E-Puimenary 19 [es fro = 70] Prous or 30 LC] fairaroacive ; Oey ene ee o 1 Cl aeeions LILI oe 3a Liteaiaoyaores | Bod LL ILE ov 2eseptnonay erie Be 39 Comet pine I Oo D Casiovaseuler 1 Cl caomyepshy I or Zo Clement eat or 30 C)omeenivencon or fe To Cotipeion or $0) Cara artythia [hie oy a nm I Cor 79 Clee ina or 33 Clavie aeons I or anos yoeréss vga! YELLOW: ——-WakCapyPINK Inet Copy COLDENRCD GRACEpage 4 Study Number Subject Number (ols) 11 LJ a SCREENING : Seon; ot [2 Spel Sonata] Corel MeN, | Rlmamanem) [SM | abel (Chock, # appbcabie,) Le Eat ; 10 [Mus 1 oe 20 [) Osteomyetits T or 3.0 [) Osteopania | i) Jy ov 4.0 (1) Collagen vascular | | oy = : So Tsai ict esi 4.0 [] Clotting problems: l | Dy 72.0 [_] Bleeding problems I or a 35 kent = “4.0 [) Transfuslons 1 oy 35 Tiga ; Oeettrocee PCa Saar 1.0 [] Peptic uicar disease: | Or wO Ganresopsngest | oy ‘3.0 C) Uvercianase [ ov aCe a = ‘6.0 [] Pancreatiie: ov = 6.0 [-] Gastointesdnal bleed [ oy 7 Ly) Ghalass at sms WaITE- coal YELLOW: WoCapy. PINK IvestgaterCopy GOLDENROD -CRA Conypage 5 Study Number i Subject Number Hi a 0\3 SCREENING 1. Prior history of 2. Specity ‘3 Onsot date “4, Currently condltionidiagnosis | (Provide specie cits below) | (Vinown,) symptomatle [check iepazabi (Gr G. Gastrointestinal (Connved 20 C] ivnvespon LI lov 30D ntannatoy bowel a seas Ov 700 CT hesiratpeastes I oy 70 Ey Font dnoion? Oma Lo Tissot 10 (Daoist ov 20 [J Obestly Oy 30 L] Hipennyrosism Ov Ta Caen 7 or 50 [ ihelled noubelo | [J ov pe 1 Sentourinary +0 [) Key dxerdor LL] ov 5 Cy winry ver inecion ov 30 C)seaaly vomited Or dees Tr We Boa 40 [Concer | ] ov rr 20 Ceska abe ay ca ase a 30 Lowe eles] a 7 [)sindiodes qe ‘ oO FTIEE] o A muna \WorTE* mal YELLOW: Wek copy PK Invetgei Copy GOLDENRSD CRA Conypage 6 Study Number Subject Number tolsL LL tJ ‘SCREENING PVT one aca) 4, Pear history of 2. Specify 3. Onset data 4, Currently Por onidlagnosis | (Provide specie detels below) | (Frown) symptomatic (Chack fapptated hack. yes) Tale Body (eonenved f “50 (J Ongalergies! ov reoetene 30 Ein dtaoar ov ‘ows a é a Cement wore De ramos LW Ef 39 Dlcroronna [ a Clerrarei Jolt Ov pe 3, Onset date 4, Currently ir Body system | Speclly Boty eben de |” free centre finer) symptomatic Srtrarbon) | _Sndepecte de Bor) (Gross). é 7 | pectin Oy % ov 7 Lo ” av 7” or ® Ty oF * Or @ Ov Bod FA ByfeRoe! 6 Neuspeed ‘ioc Popa en a. Geordie W.alabole L Oatuhary J. Whole oy 2 Ole Bay Sat ©. Puknonay—- Cardvastuer E. Nuscosteeal I ‘ans wre ofa! YELLOW. Weary PHU sbesitr Copy GOLDENROD CRA CoPypage 7 Study Number Subject Number 03 | Date of assessment SCREENING LL eons 1 Age of onsot LL] cae mentee Yn 2, Number of esizures in the last 2 months Sc ee as [lite Sapa Patttvanng 1 [eee tame Pair | teoneaiae | Sins Eero | Sera [eect Sinpa reat tveveg |] omens ] ‘econ Pl LL] [or one | Tee sno remneare, | | | loconoex Pata” Erg Gomafnd 3, ae subject ever gone inte wats eplppious? Lv Yeo ye plese cnpononion ¢aboor SN Ne “Status eptepticus type] Lifetine numbor] 6 Dat of most recent epsode cue Tiss Sip Pea | These Gani Pata ] (Css Generalized | L Leann eee ne EEE mugsv0s WHITE ofa YELLOW Wir Cony PRK Copy DLOENROD -CHA Cory