None listed
Conditions
Interventions
THE TOTAL DURATION OF THE STUDY FOR EACH PATIENT WILL BE APPROXIMATELY 18 WEKS. THERE WILL BE A SCREENING PERIOD FOLLOWED BY A 12-WEEK DOUBLE-BLIND TREATMENT PERIOD AND THEN A 3-WEEK FOLLOW-UP PERIOD.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. ADULTS AND ADOLESCENTS (AGES 16 TO 50) 2. PATIENTS MUST AGREE TO EITHER REMAIN COMPLETELY ABSTINENT OR TO USE TWO EFFECTIVE CONTRACEPTIVE METHODS FROM SCREENING UNTIL 21 DAYS (5 HALF-LIVES) AFTER THE LAST DOSE OF STUDY TREATMENT AS FOLLOWS: A) ALL MALES, INCLUDING MALE PARTNERS OF FEMALE PATIENTS, MUST USE A BARRIER METHOD OF CONTRACEPTION (E.G. CONDOM) B) ALL FEMALES OF CHILDBEARING POTENTIAL AND FEMALE PARTNERS OF MALE PATIENTS, MUST CHOOSE FROM THE FOLLOWING CONTRACEPTIVE OPTIONS: I. AN INTRAUTERINE DEVICE (IUD) WHICH WAS IMPLANTED AT LEAST 2 MONTHS PRIOR TO SCREENING II. ESTABLISHED HORMONAL CONTRACEPTION (ORAL, VAGINAL, IMPLANTED OR INJECTABLE) III. IN ADDITION TO A SPERMICIDAL AGENT (FOAM, GEL, CREAM, OR SUPPOSITORY), USE OF A BARRIER METHOD, SUCH AS A CONDOM, DIAPHRAGM, CERVICAL/VAULT CAP, OR VAGINAL SPONGE 3. CGI-S OF 3 (MILDLY ILL) OR MORE 4. ABC TOTAL SCORE OF 20 OR MORE 5. DIAGNOSIS OF FXS WITH A CONFIRMED FMR1 FULL MUTATION 6. THE PRESENCE OF A RELIABLE CAREGIVER, ABLE AND WILLING TO PROVIDE INFORMATION REGARDING PATIENT´S BEHAVIOR AND SYMPTOMS AND ABLE TO ADMINISTER TREATMENT 7. LANGUAGE, HEARING AND VISION COMPATIBLE WITH THE STUDY MEASUREMENTS 8. FOR THE MEDICATIONS ALLOWED (SECTION 4.4.1): STABLE REGIMEN FOR 4 WEEKS
Exclusion criteria
Exclusion criteria: 1. HAVE PREVIOUSLY RECEIVED TREATMENT WITH ANOTHER MGIU5 RECEPTOR ANTAGONIST WITHIN 18 MONTHS OR R04917523 2. ENROLLMENT/PARTICIPATION IN ANY INTERVENTIONAL STUDY (CLINICAL TRIAL) INVOLVING AN INVESTIGATIONAL DRUG (UNAPPROVED) OR NON-DRUG TREATMENT WITHIN THE PRIOR 3 MONTHS OR 5 TIMES THE HALF-LIFE (WHICHEVER IS LONGER) 3. HYPERSENSITIVITY TO THE EXCIPIENTS OF THE STUDY DRUG [1] 4. ANY UNCONTROLLED, UNSTABLE CLINICALLY SIGNIFICANT PSYCHIATRIC CONDITION OTHER THAN FXS THAT MAY INTERFERE WITH THE INTERPRETATION OF SAFETY AND EFFICACY EVALUATIONS 5. CURRENT SYMPTOMS OR PRESUMPTION OF PSYCHOSIS OR EUPHORIA, HISTORY OF CATATONIA, HALLUCINATIONS OR DELUSIONAL THOUGHTS 6. HISTORY OF SUICIDAL BEHAVIOR OR OTHERWISE CONSIDERED A HIGH SUICIDAL RISK BY THE INVESTIGATOR 7. SEVERE SELF-INJURIOUS BEHAVIORS THAT ARE CURRENT OR IN THE PAST 5 YEARS, WITH THE EXCEPTION OF HAND BITING 8. BEHAVIORAL DYSFUNCTION THAT WOULD PREVENT ADMINISTRATION OF THE STUDY PROCEDURES 9. ALCOHOL AND SUBSTANCE ABUSE OR DEPENDENCE IN THE PAST 6 MONTHS
Countries
Argentina, Canada, Chile, France, Mexico, Peru, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed