Question

Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1,200 subjects. Which of the following best describes the clinical phase of this study?

Answer 1

Phase III

Step-by-step explanation:

The given condition fall in the trial phase (Phase III) of cinical study which aims to:

- Determine drug's effectiveness (primary goal)

- Determine long-term drug safety

- Confirm findings

In Phase III, randomised, double-blind, placebo-controlled, parallel group study is majorly to evaluate the efficacy and safety of placebo in episodic migraine prevention in children (6 to < 12 years of age) and adolescents (12 to < 18 years of age).

The trial consists of four phases: screening; double-blind therapy period for 24 weeks in which placebo or Erenumab is given to subject as dose 1, dose 2 or dose 3 (based on the participant's body weight) once a month via subcutaneous injection; optional dose level blinded extension phase (40 weeks) which involves subjects recieve dose1, 2 and 3 of placebo, and at last it follows a safety follow-up phase for 12 weeks (after 16 weeks of the last dose of investigational drug).

Hence, the clinical phase is phase III.