Here is the design of a clinical trial:

Official Title: Colchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial

Included conditions:
- Amyotrophic Lateral Sclerosis

Study Armgroups:
- {'label': 'Colchicine 0.01mg/kg/day + Riluzole 100 mg', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral colchicine will be administered at fast, at specified dose pro kilograms for 30 weeks, while taking Riluzole 100 mg/day', 'interventionNames': ['Drug: Colchicine 1 MG Oral Tablet']}
- {'label': 'Colchicine 0.005 mg/kg/day + Riluzole 100 mg', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral colchicine will be administered at fast, at specified dose pro kilograms for 30 weeks, while taking Riluzole 100 mg/day', 'interventionNames': ['Drug: Colchicine 1 MG Oral Tablet']}
- {'label': 'Placebo + Riluzole 100 mg', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo pills will be administered at fast, while taking Riluzole 100 mg/day', 'interventionNames': ['Drug: Placebo Oral Tablet']}

Interventions:
- {'type': 'DRUG', 'name': 'Colchicine 1 MG Oral Tablet', 'description': 'Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (\\>70 kg or \\<71 kg) for 30 weeks of duration.', 'armGroupLabels': ['Colchicine 0.01mg/kg/day + Riluzole 100 mg']}
- {'type': 'DRUG', 'name': 'Colchicine 1 MG Oral Tablet', 'description': 'Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (\\>70 kg or \\<71 kg) for 30 weeks of duration.', 'armGroupLabels': ['Colchicine 0.005 mg/kg/day + Riluzole 100 mg']}
- {'type': 'DRUG', 'name': 'Placebo Oral Tablet', 'description': 'Corresponding tablets for 30 weeks', 'armGroupLabels': ['Placebo + Riluzole 100 mg']}

Primary Outcomes:
- {'measure': 'Decrease in ALS disease progression as measured by ALS Functional rating Scale Revised (ALSFRS-R)', 'description': 'ALSFRS-R is a scale that measures disability in ALS; the scores range from 0 (maximum disability, the worst score) to 48 (no disability, the best score). We will measure total score changes from baseline to week 30 in treatment and placebo arms.', 'timeFrame': 'comparison between baseline and treatment end (week 30)'}

Please estimate the sample size based on the assumption: 
The null hypothesis is that there is no difference in the percentage of positive response between the Colchicine and placebo groups. The alternative hypothesis is that Colchicine increases the positive response by at least 50% (60% vs 10%). The study is designed with an alpha error of 0.025 and a power of 0.80. An average dropout rate of 5% is considered.
Sample size calculation
        ALS progression will be assessed through the ALSFRS-R. It has been reported that ALS caring neurologists consider of clinical significance a difference of 4 points in the decline of ALSFRS-R, and that patients with ALS have on average an ALSFRS-R decline of 0.89 points/month (SD:0.13).36â38 Therefore, we can consider a mean ALSFRS-R decline in 30 weeks of 6.23, with 90% of patients presenting a decline of the ALSFRS-R total score ranging from 4.7 to 7.7.
        As a result, for this study, during the 30 weeks of treatment, we will expect that the minority (10%) of patients with ALS will not have a decline at ALSFRS-R of at least 4 points from baseline, whereas a relevant number of those treated, that we quantify in a maximum of 60%, will not have the same decline. In other words, we expect that after 30 weeks of treatment the percentage of positive response in the control group will be equal to 10%, whereas in the experimental group it will be equal to 60%.
        The null hypothesis is that the percentage of positive response (increase of ALSFRS-R <4 points at 30 weeks) between Colchicine and placebo groups will not differ after 30 weeks of treatment.
        The alternative hypothesis is that Colchicine determines an increase of positive response compared to placebo of at least 50%, in absolute scale (60% vs 10%).
        The study has been designed to reject the null hypothesis with an alpha error of 0.025 (to take into account a multiple comparison with a control arm) and a power of 0.80. For this purpose, a sample of 51 patients randomised in 3 arms would be needed. Considering an average drop out of 5%, a recruitment of 54 patients will be necessary.